1. DIA Trial Master File Reference Model

2. EDM Reference Model
DIA Document and Records Management Special Interest Area Community initiative since 2008
Standardization effort for the industry with eCTD backbone
Version 1 launched in 2008, update in the works
Extensions of the model are in development
Interconnects with TMF Reference Model in trial related submission documentation
Ensure mapping of taxonomy and alignment of metadata

3. Why a TMF Reference Model?
ICH GCP Section 8.2 – 8.4
“The minimum list of essential documents that has been developed.....”
ICH GCP does NOT provide a comprehensive contents list for the TMF
Examples of missing documentation:
Electronic systems
Data management and statistical methodology
Safety monitoring

4. The Trial Master File The Trial Master File
Supporting files e.g. computer SDLC files; GMP manufacturing files; vendor selection files
Other business records
Minimum list of essential documents, as defined by ICH GCP, Chapter 8
Other trial-related records that “permit evaluation of the conduct of the trial and quality of data produced”
Usually considered outside the scope of the TMF
The Trial Master File

5. TMF Reference Model Goals
Standard contents
Industry opinion on what is kept in a TMF
Standard naming
Based off the ICH E6 Section 8 terminology and industry accepted terminology
Standard structure
It doesn’t have to be folder-based or departmentalized like in a paper system
Standard metadata
If TMF is an EDMS, what would be the basics – at system and artifact level?
This slide gives an high-level description of how we currently file TMF documents 5

6. 1.5 years of Accomplishments
Dec08-Feb09
DIA EDM meetings to recruit team members
Mar09
Inaugural meeting and charter created
May09
TMF split into zones, Leads and members organized
Aug09
First pass at TMF contents (artifacts) and naming
Sep09
Feedback from TMF reference model members and extended review team
Dec 2008 – Feb 2009 – DIA EDM meetings to talk up the topic and recruit team
March 2009 –
May
Aug 2009 –
Sept 2009 –
Dec 2009 –
Mar10
Artifacts narrowed, definitions added, requirement level and metadata requirements in refinement
Jun10
Version 1.0 release 6

7. How Work on the Model is Organized?
11 Zones and 222 Artifacts
Trial Management
Central Trial Documents
Regulatory
IRB/IEC and other Approvals
Site Management
IP and Trial Supplies
Safety Reporting
Centralized Testing
Third Parties
Data Management
Statistics 7

8. Who’s Been Involved? 139 members on team 98 Companies
55% US, 45% EU
98 Companies
Pharma
CRO
Vendor
Regulatory agency review
MHRA
FDA 8

9. TMF Reference Model
Version 1.0 Overview

10. Artifact Definition

11. Core / Recommended, ICH & EDM

12. Metadata

13. Overall Model

14. Using the TMF Reference Model for paper

15. Future Plans Linked in group (TMF Reference Model)
Continued connection with industry representatives
Coordinated feedback on the utilization of the model by sponsors, CROs, and vendors
Version 1.1 expected by Dec / early 2011
Technical guide to the model
Version 2.0 of model expected by June 2011 may include:
Device Studies
Early phase studies
Investigator Initiated Studies
Regional expansive view